Cryptopain compositions for prophylaxis, treatment, diagnosis and detection of cryptosporidium species

Abstract

Vaccines, antibodies, proteins, DNAs and RNAs for diagnosis, prophylaxis, treatment and detection of Cryptosporidium species or Cryptosporidium species infections. Cryptosporidium species antigen and DNAs and RNA encoding the Cryptosporidium antigen and fragments thereof and recombinant proteins or fusion proteins produced thereby. Methods for diagnosis, prophylaxis, treatment and detection of Cryptosporidium species infections.

1 - 18 . (Cancelled)  
     
     
         19 . An antibody binding to a  Cryptosporidium  cryptopain antigen comprising an amino acid sequence selected from the group consisting of SEQ ID NO: 4 and SEQ ID NO: 6.  
     
     
         20 . The antibody of  claim 19 , binding to the amino acid sequence of SEQ ID NO: 6.  
     
     
         21 . The antibody of  claim 19 , wherein the antibody is selected from the group consisting of monoclonal and polyclonal.  
     
     
         22 . The antibody of  claim 19  detecting a presence of  Crytosporidium  by formation of an antibody-antigen complex.  
     
     
         23 . The antibody of  claim 22  wherein the antibody is polyclonal.  
     
     
         24 . The antibody of  claim 22  wherein the antibody is monoclonal.  
     
     
         25 . A method of treatment of  Crytosporidium  infections comprising administering to a subject in need of such treatment either an anti- Crytosporidium  antibody binding to a protein comprising a sequence of SEQ ID NO: 4, SEQ ID NO: 6 or a fragment thereof, or a DNA or RNA vaccine comprising a DNA sequence identified as SEQ ID NO: 1 or a fragment thereof.  
     
     
         26 . The method of  claim 25  wherein the antibody is polyclonal.  
     
     
         27 . The method of  claim 25  wherein the antibody is monoclonal.  
     
     
         28 . The method of  claim 25  comprising administration of an anti- Crytosporidium  vaccine comprising the  Crytosporidium  antigen cryptopain comprising the amino acid sequence of either SEQ ID NO: 5 or SEQ ID NO: 6.  
     
     
         29 . The method of  claim 25  wherein the vaccine further comprises an adjuvant.  
     
     
         30 . The method of  claim 28  wherein the vaccine comprises the amino acid sequence of SEQ ID NO: 5.  
     
     
         31 . The method of  claim 28  wherein the vaccine comprises the amino acid sequence of SEQ ID NO: 6.  
     
     
         32 . The method of  claim 25  wherein the vaccine comprises the DNA sequence of SEQ ID NO: 1 or the fragment thereof identified as SEQ ID NO: 2 or SEQ ID NO: 3.  
     
     
         33 . The method of  claim 25  wherein the vaccine comprises the DNA sequence identified as SEQ ID NO: 1.  
     
     
         34 . The method of  claim 25  wherein the vaccine comprises the DNA fragment identified as SEQ ID NO: 2.  
     
     
         35 . The method of  claim 25  wherein the vaccine comprises the DNA fragment identified as SEQ ID NO: 3.  
     
     
         36 . A method of diagnosing  Crytosporidium  infection, comprising: 
 (a) contacting a sample of a body specimen, fluid or tissue obtained from a subject, with an anti- Crytosporidium  antibody having specificity for an antigen identified by an amino acid sequence of either SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, or a fragment thereof; and    (b) detecting a formation of an antibody/antigen complex in the sample.    
     
     
         37 . The method of  claim 36  wherein the antibody binds to the antigen identified by the amino acid sequence of SEQ ID NO: 4.  
     
     
         38 . The method of  claim 36  wherein the antibody binds to the antigen identified by the amino acid sequence of SEQ ID NO: 5.  
     
     
         39 . The method of  claim 36  wherein the antibody binds to the antigen identified by the amino acid sequence of SEQ ID NO: 6.  
     
     
         40 . A polyclonal anti-cryptopain antibody suitable for treatment of  Crytosporidium  infections wherein said antibody is administered to a person in need of such treatment, said antibody produced against a recombinant  Crytosporidium  cryptopain antigen having an amino acid sequence of either SEQ ID NO: 4 or SEQ ID NO: 6, said antibody binding to said cryptopain antigen, 
 wherein said antibody is administered in an amount effective to provide immunity or to inhibit existing  Crytosporidium  infection.    
     
     
         41 . The antibody of  claim 40  raised against a cryptopain antigen having an amino acid sequence of SEQ ID NO: 4.  
     
     
         42 . The antibody of  claim 41  raised against a cryptopain antigen having an amino acid sequence of SEQ ID NO: 6.  
     
     
         43 . A polyclonal or monoclonal anti- Crytosporidium  antibody suitable for detecting  Crytosporidium  in a biological or environmental sample wherein said antibody is contacted with a biological sample specimen or with an environmental sample suspected to be infected with  Crytosporidium , wherein said antibody is produced against a recombinant  Crytosporidium  cryptopain antigen having amino acid sequence of either SEQ ID NO: 4 or SEQ ID NO: 6, and binds to cryptopain antigen of either SEQ ID NO: 4 or SEQ ID NO: 6.  
     
     
         44 . The antibody of  claim 43  in an anti-cryptopain antibody/cryptopain antigen complex in the biological or environmental sample.  
     
     
         45 . The antibody of  claim 43  wherein the anti-cryptopain antibody/cryptopain antigen complex is detected with either an enzyme-linked immunoassay or with a radioactive assay.  
     
     
         46 . The antibody of  claim 45  wherein the formation of the anti-cryptopain antibody/cryptopain antigen complex is detected by solid phase method, with double antibody assay, sandwich double antibody assay or triple antibody assay or ELISA.  
     
     
         47 . The antibody of  claim 45  which detects a presence of the anti-cryptopain antibody/cryptopain antigen complex of  Crytosporidium  in a tissue, fluid, or biological sample.  
     
     
         48 . The antibody of  claim 43  which detects a presence of the anti-cryptopain antibody/cryptopain antigen complex in a stool, urine, saliva, blood or serum sample specimen.  
     
     
         49 . The antibody of  claim 43  wherein the antibody binds specifically to SEQ ID NO: 6.